MedTrace Logo

Evaluation of a Daily Oral Care Lozenge on Oral Health and Quality of Life in Older Adults

NCT03693027 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-09

No results posted yet for this study

Summary

The assessment of a daily oral care lozenge (PTx800) will be compared to a placebo control in a cohort of older adults who visit adult senior centers and who also have mild to moderate gingivitis. The comparison of the pre-to post change in gum health and pathogen burdens will be measured over a 6 week period. In addition, the feasibility and acceptability of using the lozenges will be assessed in this older adult population.

Conditions

  • Oral Health

Interventions

DIETARY_SUPPLEMENT

PTx800 lozenges

PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.

DIETARY_SUPPLEMENT

Placebo control

The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.

Sponsors & Collaborators

  • Benjamin Rose Institute on Aging

    collaborator OTHER

  • Primal Therapies Inc.

    lead INDUSTRY

Principal Investigators

  • Emily Stein · Primal Therapies

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-12-20
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03693027 on ClinicalTrials.gov